Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | ADVIA CENTAUR AHBS ASSAY |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 333 Coney Street Walpole, MA 02032 |
PMA Number | P030029 |
Supplement Number | S008 |
Date Received | 08/21/2009 |
Decision Date | 09/15/2009 |
Withdrawal Date
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05/24/2016 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE FROM 20 GRAMS TO 60 GRAMS FOR THE ANTI-HBS WETCAKE USED IN THE PRODUCTION OF AHBS REAGENT. |
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